Reality hits ALX

After months trying to persuade the markets that evorpacept could get accelerated approval for gastric cancer based on a subgroup of the failed Aspen-06 trial, ALX Oncology has accepted that it can't. This, the company says, follows feedback from the FDA, which as a condition of approval has asked for a phase 3 study comparing evorpacept versus Enhertu; ALX will not run one, and has given up on this setting. The lack of a comparison against Enhertu was always a problem for Aspen-06, even when its first response data appeared to deliver a positive outcome in 2023. The ORR numbers subsequently worsened, and last August Aspen-06 was declared a bust – only to be resurrected in January courtesy of a subgroup of patients in whom fresh HER2 biopsies were available. Clearly the lack of comparison against a recently established standard of care proved to be a bigger stumbling block than any nuances about cherrypicked subgroups, though investors shrugged off the setback, sending ALX stock down just 5% on Thursday. Evorpacept has delivered numerous disappointments, most recently failing in the head and neck cancer trials Aspen-03 and 04, and in the Aspen-07 Padcev combo study in bladder cancer.